Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency […]
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s […]
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, […]
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put […]
US HHS Picks 27 Drugs for Inflation Rebates
A recent rule will let the US Department of Health and Human Services (HHS) require drugmakers to pay back rebates on drugs that increase in price faster than inflation. The department has announced its list of the first 27 drugs to face this process, including therapeutics from pharma giants like […]
Which Drugmakers Will Face US Drug Pricing Negotiations in 2026?
Although many likely contenders have been named, the first slate of drugs to face Medicare drug pricing negotiations in 2026 is yet to be determined. The first 10 drugs to be selected will be announced in September, likely including cancer drugs from AbbVie and Pfizer and BMS’s blood thinner […]
Pharma’s Take on Drug Pricing Data Transparency in South Korea
Korea’s drug pricing policies are complex and lack transparency, according to Eli Lilly Korea’s General Manager Christopher J. Stokes. Stokes notes that he has spent considerable time talking with other pharma leaders, who generally agree with his take on the complicated nature of the South Korean […]
Lilly and Boehringer’s Type II Diabetes Drug Gets Expanded Approval from FDA for Use in Children
Eli Lilly and Boehringer Ingelheim secured approval from the US Food and Drug Administration (FDA) to expand the indications of its diabetes drug Jardience. The new indications include children under 10 with type 2 diabetes, a growing population in recent years. The drug would be the first in its […]
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only […]
New US Bill Challenges Use of QALY in Drug Value Assessments
Quality-adjusted life years (QALY) is a metric widely used when determining the cost-effectiveness of a drug, often when deciding upon or recommending drug prices. A new bill was approved by the US House Energy and Commerce Health Subcommittee that would, if passed, end the practice of using QALY in […]
